What works for whom in pharmacist-led smoking cessation support: realist review

Background New models of primary care are needed to address funding and staffing pressures. We addressed the research question “what works for whom in what circumstances in relation to the role of community pharmacies in providing lifestyle interventions to support smoking cessation?” Methods This is a realist review conducted according to RAMESES standards. We began with a sample of 103 papers included in a quantitative review of community pharmacy intervention trials identified through systematic searching of seven databases. We supplemented this with additional papers: studies that had been excluded from the quantitative review but which provided rigorous and relevant additional data for realist theorising; citation chaining (pursuing reference lists and Google Scholar forward tracking of key papers); the ‘search similar citations’ function on PubMed. After mapping what research questions had been addressed by these studies and how, we undertook a realist analysis to identify and refine candidate theories about context-mechanism-outcome configurations. Results Our final sample consisted of 66 papers describing 74 studies (12 systematic reviews, 6 narrative reviews, 18 RCTs, 1 process detail of a RCT, 1 cost-effectiveness study, 12 evaluations of training, 10 surveys, 8 qualitative studies, 2 case studies, 2 business models, 1 development of complex intervention). Most studies had been undertaken in the field of pharmacy practice (pharmacists studying what pharmacists do) and demonstrated the success of pharmacist training in improving confidence, knowledge and (in many but not all studies) patient outcomes. Whilst a few empirical studies had applied psychological theories to account for behaviour change in pharmacists or people attempting to quit, we found no studies that had either developed or tested specific theoretical models to explore how pharmacists’ behaviour may be affected by organisational context. Because of the nature of the empirical data, only a provisional realist analysis was possible, consisting of five mechanisms (pharmacist identity, pharmacist capability, pharmacist motivation and clinician confidence and public trust). We offer hypotheses about how these mechanisms might play out differently in different contexts to account for the success, failure or partial success of pharmacy-based smoking cessation efforts. Conclusion Smoking cessation support from community pharmacists and their staff has been extensively studied, but few policy-relevant conclusions are possible. We recommend that further research should avoid duplicating existing literature on individual behaviour change; seek to study the organisational and system context and how this may shape, enable and constrain pharmacists’ extended role; and develop and test theory.

What works for whom in pharmacist-led smoking cessation support: realist review

Greenhalgh et al. BMC Medicine
What works for whom in pharmacist-led smoking cessation support: realist review
Trisha Greenhalgh 0
Fraser Macfarlane 1
Liz Steed 1
Robert Walton 1
0 Nuffield Department of Primary Care Health Sciences, University of Oxford , Oxford , UK
1 Asthma UK Centre for Applied Research, Centre for Primary Care and Public Health, Barts and The LondonSchool of Medicine and Dentistry, Queen Mary University of London , London , UK
Background: New models of primary care are needed to address funding and staffing pressures. We addressed the research question “what works for whom in what circumstances in relation to the role of community pharmacies in providing lifestyle interventions to support smoking cessation?” Methods: This is a realist review conducted according to RAMESES standards. We began with a sample of 103 papers included in a quantitative review of community pharmacy intervention trials identified through systematic searching of seven databases. We supplemented this with additional papers: studies that had been excluded from the quantitative review but which provided rigorous and relevant additional data for realist theorising; citation chaining (pursuing reference lists and Google Scholar forward tracking of key papers); the 'search similar citations' function on PubMed. After mapping what research questions had been addressed by these studies and how, we undertook a realist analysis to identify and refine candidate theories about context-mechanism-outcome configurations. Results: Our final sample consisted of 66 papers describing 74 studies (12 systematic reviews, 6 narrative reviews, 18 RCTs, 1 process detail of a RCT, 1 cost-effectiveness study, 12 evaluations of training, 10 surveys, 8 qualitative studies, 2 case studies, 2 business models, 1 development of complex intervention). Most studies had been undertaken in the field of pharmacy practice (pharmacists studying what pharmacists do) and demonstrated the success of pharmacist training in improving confidence, knowledge and (in many but not all studies) patient outcomes. Whilst a few empirical studies had applied psychological theories to account for behaviour change in pharmacists or people attempting to quit, we found no studies that had either developed or tested specific theoretical models to explore how pharmacists' behaviour may be affected by organisational context. Because of the nature of the empirical data, only a provisional realist analysis was possible, consisting of five mechanisms (pharmacist identity, pharmacist capability, pharmacist motivation and clinician confidence and public trust). We offer hypotheses about how these mechanisms might play out differently in different contexts to account for the success, failure or partial success of pharmacy-based smoking cessation efforts. Conclusion: Smoking cessation support from community pharmacists and their staff has been extensively studied, but few policy-relevant conclusions are possible. We recommend that further research should avoid duplicating existing literature on individual behaviour change; seek to study the organisational and system context and how this may shape, enable and constrain pharmacists' extended role; and develop and test theory.
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Background
New models of primary care are urgently needed to
address funding and staffing pressures. One such model is
an extended role for the community pharmacist. In the
UK, for example, the contract for community
pharmacists was revised in 2005 to embrace three levels of
service: essential (basic dispensing and medicines advice),
advanced (e.g. extended professional services such as
smoking cessation support and medicines use review),
and enhanced (locally commissioned services to address
local priorities) [1]. As in many other countries, the
community pharmacy is seen as an accessible and
potentially cost-effective venue for providing a range of public
health services and targeting particular needs at a time
when general practice is under unprecedented strain [2].
Yet, uptake of the extended role of the pharmacist has
been lower than expected both in the UK and elsewhere
[2, 3]. Smoking cessation is a priority area for health
promotion and one in which pharmacists showed early
interest [4].
The STOP programme is a mixed-methods research
study that aims to answer the over-arching research
question “Will a personalised smoking cessation
intervention delivered in community pharmacies (and
including an education programme to develop workers’
engagement and consultation skills) improve
engagement in the NHS Stop Smoking service and quit rate
in smokers?” [5].
The other elements of the STOP programme are
(1) a systematic review of behavioural interventions in
community pharmacies, beginning with a quantitative
review of (mostly) randomised controlled trials (RCTs)
but including other controlled designs, according to
Cochrane Effective Practice and Organisation of Care
(EPOC) criteria [6]; (2) qualitative observational
studies of pharmacist–patient consultations relating to
smoking cessation; (3) development and piloting of an
educational intervention for community pharmacy
workers; and (4) a pragmatic cluster randomised trial
(1200 patients, 60 pharmacies) to evaluate the
effectiveness of the educational intervention in both
promoting uptake of the NHS Pharmacy Smoking
Cessation Service and increasing quit rates. The trial
will also collect data on costs and adverse events.
This study, part of the qualitative and mixed-methods
component of our background literature review, aimed to
identify and analyse theoretical and empirical data on the
context and process of pharmacist-led smoking cessation
support programmes.
1. Identify studies of pharmacy-based smoking cessation interventions.
2. Identify additional relevant publications that would contribute to theory building about what works for whom in what circumstances.
3. Gain familiarity with the dataset by close reading.
4. Produce a descriptive summary of the data to
summarise what kinds of research question have
been asked, how these questions have been
addressed and what the key findings are to date.
5. Develop a realist analysis consisting of candidate
theories linking context, mechanism and outcome.
6. Undertake systematic data extraction to test and refine these candidate theories.
7. Summarise the middle-range theories for which there is strong empirical evidence of what works for whom in what circumstances.
8. Clarify gaps in the knowledge base and make recommendations for further research.
Realist review
The principles of realist review have been described in
more detail elsewhere [7]; we summarise them briefly here.
The realist research question is often summarised
as “What works for whom in what circumstances,
how and why?” [7]. Realist inquiry considers the
interaction between context (the organisational and
system setting in which complex interventions are
delivered), mechanism (how the intervention works) and
outcome. Complex interventions rarely have a constant
effect size. They are usually more effective in some
circumstances than others. Intervention X (e.g. a programme
introduced by policymakers who seek to create a
particular outcome) alters context (for example, by making new
resources available), which then triggers mechanism(s)
(“…underlying entities, processes, or [social] structures
which operate in particular contexts to generate outcomes
of interest” [8]), which produce both intended and
unintended outcomes.
Realist inquiry seeks to unpack the
context–mechanism–outcome relationship, thereby explaining examples
of success, failure and various eventualities in between.
Theoretical explanations of this kind are referred to as
“middle-range theories” (i.e. ones which involve a certain
amount of abstraction but which are close enough to
observed data to be incorporated in propositions that
permit empirical testing). Examples of middle-range theory
are given later in the paper.
An international Delphi panel published the
RAMESES quality standards and publication guidance for
realist review in 2013 [9]. This review was undertaken
with reference to those standards.
Research questions
As is usually the case in realist review, our
overarching research question “what works for whom in
what circumstances in relation to the role of
community pharmacies in providing lifestyle interventions to
support smoking cessation?” was refined to a number
of more specific questions as the review unfolded.
These comprised five descriptive questions and one
higher-order (realist) question. Respectively, these
were:
1. What is the impact on pharmacists of training them in smoking cessation support?
2. What is the perspective of patients and the public
on pharmacy-based smoking cessation support?
3. What do pharmacists perceive are the barriers to
delivering smoking cessation support?
4. What do pharmacists believe would help them to deliver smoking cessation support?
5. How do organisational and system factors influence uptake and delivery of smoking cessation counselling by pharmacists?
6. How do the key mechanisms of pharmacist identity,
pharmacist capability, pharmacist motivation,
clinician confidence and public confidence interact
with contextual influences and with one another to
explain the successes, failures and partial successes
of pharmacy-based smoking cessation schemes?
Sample
Data collection occurred from January to June 2016.
Our sampling strategy is summarised in the flowchart
(Fig. 1).
We began with the sample of studies included in
the STOP quantitative review [10]. These had been
identified previously through systematic searching of
seven databases (Cochrane Central Register of
Controlled Trials, Health Technology Assessment
Database, NHS Economic Evaluation Database, Medline
including in-process citations, EMBASE, PsycINFO,
EPOC). These studies consisted mostly of RCTs of
community pharmacy-based behavioural interventions,
in relation to both smoking cessation and a range of
other behaviours (e.g. weight management, sexual
health, asthma). They also included linked (‘sister’)
publications, that is, papers by the same authors,
describing further analysis or commentary on the same
original dataset and/or additional empirical studies,
qualitative evaluations, critiques or commentaries by
other authors.
For the purposes of this realist review, we were
interested less in quantitative findings of
intervention studies (e.g. effect sizes) per se than in the
nuanced explanations of why a particular intervention
had been more or less successful at influencing the
target behaviour. Therefore, not all the studies in
this sub-sample were relevant. One of us (TG)
reviewed the full-text papers and made a judgement
as to whether the paper included sufficient
descriptive detail and/or theoretical discussion to
contribute to the development and/or testing of
theorydriven explanations about why and how a
community pharmacy delivered smoking cessation
intervention might work. Studies lacking descriptive detail
were not considered further. A 10% sub-sample of
included and excluded papers was checked by FM;
differences were minimal.
We supplemented this initial sample with relevant
additional papers from three sources. First, we also
considered studies that had been excluded from the EPOC
review of quantitative findings but which provided
rigorous and relevant additional data for realist theorising.
Aspects of a study may be relevant for theory building
even when the study’s main research question is
marginal or when some aspects of the study (e.g. outcome
measures) did not meet the review’s inclusion criteria. In
particular, some studies had been rejected from the
EPOC review because they did not have a clinically
validated measure of smoking cessation but nevertheless
could contribute key contextual detail to this
theoryfocused review.
Second, taking account of the efficiency and
effectiveness of ‘fuzzy’ search methods in identifying key
papers in reviews of complex and heterogeneous topic
areas [11], we undertook citation chaining (pursuing
reference lists and Google Scholar forward tracking)
of all papers that we judged to be centrally relevant
to our realist question. The reference lists of these
papers identified studies that had been published prior to
them, and Google Scholar identified studies published
subsequently that cited them.
Third, and again reflecting the value of ‘fuzzy’ search
methods, we used the ‘search similar citations’ function
on PubMed. We entered the title of each key paper in
Fig. 1 Study flowchart
turn, and considered the titles of studies offered by the
software as ‘similar’ to the one entered.
In each of these three steps, many papers could be
excluded as irrelevant on title and abstract alone, but
where necessary we obtained the full text of the
paper to consider whether it included sufficient
detailed description on a rigorous and relevant aspect of
the study and/or sufficient theoretical discussion to
add to our emerging synthesis – and in particular
whether it might contribute to the development and
refinement of programme theories. Judgements were
made by TG and a 10% sample checked by FM with
no substantial discrepancies.
Descriptive analysis
In order to gain familiarity with the data, all full-text
papers deemed relevant were initially read and re-read
by FM and TG, and a preliminary thematic analysis
undertaken using a combination of paper annotations
and an Excel spreadsheet to aid data management. In
this phase, we sought to gain an overview of how
researchers had studied the provision of smoking cessation
support by pharmacists, to identify examples of highly
successful programmes and also unsuccessful ones, and
to highlight explanations (e.g. from the discussion
sections of the empirical studies) that could serve as
candidate theories to be tested further in the next phase
of the study.
We used an Endnote database to classify each
publication in each of four categories: study design, academic
discipline, country and methodological rating.
‘Study design’ included primary designs
(e.g. RCT, qualitative study) and secondary
designs (e.g. systematic review of RCTs,
systematic review of qualitative studies).
‘Academic discipline’ referred to the broad
research tradition in which the study was located
(assessed by judging the academic department
of the lead author, the journal in which it was
published and the literature it cited). Examples
of academic disciplines were public health
(an interdisciplinary field of study focused on
the health of communities or sub-populations),
pharmacy practice (the study by pharmacists
of what pharmacists do), and health economics
(the study of the costs and cost-effectiveness of
health interventions).
‘Country’ referred to the country in which a
primary empirical study had been undertaken;
for secondary research, it was the country of the
lead author.
‘Methodological rating’ was an estimate
(on a 3-point scale) of the methodological
quality of the study. We gave three stars to
studies that had no major flaws within their
genre and were adequately powered to provide
a definitive answer to the authors’ research
question; two stars to studies that were too
small to provide definitive answers but were
otherwise methodologically robust, and one star
to studies that had significant flaws
(most commonly small studies in a parochial
setting whose findings could not be generalised
with any confidence).
The methodological rating for each individual study
was used as an interim metric to contribute to a
modified ‘strength of evidence’ score based on the World
Health Organization Health Evidence Network criteria
[12]:
Strong direct evidence: consistent findings in
two or more empirical studies of appropriate
design and high scientific quality (3 stars in our
rating) relating directly to the provision of
smoking cessation support by community
pharmacists or pharmacy workers overseen by
pharmacists.
Strong indirect evidence: consistent findings in
two or more empirical studies of appropriate
design and high scientific quality, relating to the
provision of some other behavioural intervention
by community pharmacists or pharmacy
workers.
Moderate direct (or indirect) evidence:
consistent findings in two or more empirical
studies of less appropriate design and/or of
acceptable scientific quality (two stars in our
rating) relating directly to the provision of
smoking cessation support
(or indirectly to the provision of some other
behavioural intervention) by community
pharmacists or pharmacy workers overseen by
pharmacists.
Limited evidence: only one study of appropriate
design and acceptable quality (two stars)
available, or inconsistent findings in several
studies.
No evidence: no relevant study of acceptable
scientific quality available.
Because of a dearth of theoretical data in the
primary empirical studies, it proved possible to use this
rating scale only in the descriptive phase of the
review.
Realist analysis
In order to identify aspects of each empirical study
that were key to the intervention’s success (or which
explained its failure or partial success), we initially
planned to extract data on (1) the nature of the
intervention; (2) aspects of the context in which it was
implemented; and (3) how the intervention was
assumed (or shown) to work. Ideally, such data would
be found prospectively in the methods and findings
sections (in other words, both data collection and
analysis would have been theory-driven). However,
when this was not the case, we used the more
speculative source of the retrospective explanations offered
by authors in the discussion sections of their papers.
In this way, we developed a preliminary set of
‘candidate theories’, for which we then sought affirming or
refuting evidence from further studies.
With a view to identifying data that would help us
assess the plausibility and strength of evidence for
particular context–mechanism–outcome
configurations, we developed and refined a data analysis
matrix, initially oriented to the candidate theories
identified above and adding further theories as these
emerged. When developing and populating this
matrix, FM and TG held regular discussions and
considered whether key data items pertained to context,
mechanisms or outcome.
Ideally, a realist analysis would surface a number of
candidate theories from empirical studies and then find
additional studies that had prospectively tested the same
theories. The analysis would then focus on which of the
initial candidate theories was supported by empirical
evidence; some theories would be rejected and others
extended and refined, producing a definitive list of
programme theories. In the study reported here, the
empirical evidence base was insufficient to support
systematic testing of candidate theories, so these theories were
presented as emerging hypotheses (rather than as
definitive statements) about what works for whom in what
circumstances.
Since very few primary studies had prospectively
identified and tested theories, tentative theory was built from
the descriptive data by considering the ‘barriers’ and
‘facilitators’ identified in the results sections of primary
studies along with authors’ reflections on the how and
why these had played out (usually found in the
discussion sections of those studies). We also considered
relevant policies and how these had unfolded, to identify the
‘theories incarnate’ embedded in policy programmes.
Finally, as tentative theories emerged, we returned to
our sample of primary studies and looked for empirical
data to support them and also disconfirming data that
might refute (or require us to modify) them. An example
of how this was done is shown in Box 1.
Most studies of pharmacist behaviour consisted of interviews
with pharmacists asking whether and how they provided
smoking cessation support or other extended role activities,
what the pharmacists thought facilitated or interfered with this
behaviour, and a commentary on these findings.
One review, for example, described primary interview studies in
which pharmacists had talked confidently about their dispensing
role but expressed reservations about their extended role. The
latter uncertainties, suggested the reviewers, “…were related to
pharmacists’ undergraduate training, which was primarily based on
the biomedical model of health […and other influences].” [13].
To explore the contextual influence of undergraduate training
further, we returned to our sample of papers and looked for any
mention of this influence. A narrative review undertaken as
background to an empirical study published 11 years later
summarised how the same theme had emerged as significant in
further studies [3]. In sum, and consistently across studies, when
asked to account for their reluctance to take on a public health
role, pharmacists emphasised that they had been trained as
dispensers of medicines and found that this jarred with the health
promotion role they were now expected to adopt.
We also identified from before-and-after studies of pharmacist
training two key attitudinal changes that were consistently
improved with training, namely ‘gives broader (less biomedical)
definition of health’ and ‘views own role as more patient-oriented
(as opposed to product-oriented)’. These findings supported the
emerging theory that training influences the kind of pharmacist
the person feels they are.
The Saramunee paper also highlighted the Modernising Pharmacy
Careers initiative in England (which began in 2009), a major
component of which was shifting the focus of education beyond
a biomedical model in order to prepare pharmacists for the
extended role expected of them by policymakers [14]. In other
words, there was already a ‘theory incarnate’ in pharmacist
training policy. This had not been empirically tested but reflected
the professional wisdom of pharmacy educators.
Finally, we prospectively looked for disconfirming data (that is,
data that would challenge the theory that a ‘biomedical’
undergraduate education helps create a more ‘biomedical’
pharmacist identity) in every study in our sample, and found none.
12 systematic reviews (5 of RCTs of pharmacist-led
behavioural interventions for smoking [15–19], 1 of
process elements of such interventions [20], 3 of
pharmacist-led behavioural interventions other than
smoking cessation [15, 19, 21], 1 of the scope of
pharmacy practice [4], 1 of pharmacists’ perceptions
[13], and 1 of qualitative studies of the patient
experience [22]);
6 reviews not described as ‘systematic’, of pharmacy
business models, pharmacist scope of practice,
pharmacist training programmes or the process
elements of RCTs [2, 23–27];
18 RCTs, of which 14 related to smoking cessation
[28–41] and 4 to other behavioural interventions
[42–45];
1 cost-effectiveness study linked to a RCT [40];
1 paper describing additional process detail on a
RCT [46];
12 evaluations of pharmacist training courses,
using either pre-post classroom assessments or
‘mystery shopper’ assessments of performance in
practice, comprising 2 linked to RCTs [28, 29]
and 10 before and after studies [47–56];
7 papers reporting quantitative surveys
(6 of pharmacists [57–62] and 4 of service
users [57, 58, 63, 64]);
6 papers describing qualitative studies, 5 based
on semi-structured interviews (3 of pharmacists
[3, 65, 66], 1 of pharmacy owners [67], 2 of service
users [3, 65], 1 of researchers [68]) and 1 a focus
group study of service users [69];
2 in-depth case studies [70, 71];
2 business models [67, 72];
1 paper describing the development of a complex
intervention [73].
We classified the main underpinning academic
discipline of the 65 papers as pharmacy practice (41), public
health (7), psychology (5), medicine (including
respiratory medicine and general practice (4), business and
management (5), health policy (2), and health economics
(2). In sum, most of the papers in this dataset described
studies that had been undertaken by pharmacists and
published from schools of pharmacy, and which were
primarily concerned with demonstrating what
pharmacists and their staff could do. The included primary
research studies covered work in 10 countries, including
UK (18), USA (15), Australia (5), Canada (4), and Ireland,
Japan, Netherlands, Qatar, Sweden, Peru and Thailand (1
each). Systematic reviews and commentaries covered
additional countries. One international comparative study
covered 27 European countries [72] and a ‘grey literature’
report from the International Pharmaceutical Association
covered advanced practice in 48 countries [25].
Of the 66 papers, 26 were classed as one star (significant
flaws or so small and parochial that generalisability was in
serious doubt). However, 21 studies were rated 2 stars and
19 (including 12 systematic and narrative reviews) were rated
3 stars. In sum, whilst many primary studies were unreliable,
there was also a substantial body of adequately powered,
well-conducted research on some though not all aspects of
our research question, including several systematic reviews.
The sample of studies identified for this review was
highly skewed towards the study of individual factors
influencing behaviour (of either pharmacists or service
users) and allowed us to draw definitive conclusions about
these aspects of the review. However, the primary studies
in our sample included very little empirical data on
organisational and system factors. For example, surveys of
attitudes, knowledge and perceptions were common, whereas
no study had used organisational ethnography to study the
complexities of the work environment or formally analysed
the implications of proposed changes for pharmacy
workforce planning (though some review articles and
commentaries had speculated on these themes). In short, we had
much data on ‘mechanisms’ but very little on ‘contexts’.
Few studies in our sample included theorisation by the
authors (or contained sufficient descriptive detail to allow us
to theorise) about the interaction between context,
mechanism and outcome. Studies typically included only brief
speculation about why an intervention might work better in
some circumstances than others, and these discussions were
invariably framed in terms of ‘barriers’ and ‘facilitators’. So,
for example, ‘lack of time’ was widely considered to be a
barrier to pharmacist-led smoking cessation provision, but
authors did not go on to consider the circumstances in which
lack of time might come to be less of a barrier. Thus, the
literature provided useful information on the individual factors
influencing pharmacist provision of this service, but not on
how these factors interacted with one another.
For all these reasons, much of our synthesis is
descriptive rather than theoretical and the realist analysis that
follows is very preliminary.
Descriptive findings
None of the studies included in this review had attempted
a realist analysis. We felt that, in order to be faithful to
what authors actually did, our findings should first be
presented in terms of the research questions asked by the
original authors (rather than in terms of the questions we
ourselves subsequently imposed on their work). In this
section, we describe the main research questions asked by
other scholars in this field and judge the nature and quality
of empirical findings.
Question 1: What is the impact on pharmacists of training
them in smoking cessation support?
In the absence of specific training, pharmacists may be
under-confident in their own ability to deliver smoking
cessation support and may not consider it part of their role.
Training has been shown to be positively received by
pharmacists (strong direct evidence [54, 74]); it increases their
knowledge (strong direct evidence: [49, 53, 54, 74, 75]),
self-efficacy or confidence (strong direct evidence: [53, 54,
74, 75]) and intention to provide such support to their own
clients (strong direct evidence: [53, 55]). These changes
appear to be sustained over the medium term (moderate
direct evidence [53, 56]). A well-designed training course may
shift the pharmacist from a biomedical and
productoriented perspective – that is, considering their own role in
terms of the dispensing of drugs and devices – to a more
public health and patient-oriented one – that is,
considering their role in terms of promoting health in the local
community and supporting individuals with lifestyle change
(moderate direct evidence: [13, 53]).
Pharmacists trained in smoking cessation support are
more likely to deliver it, spend longer on it and adhere
to evidence-based standards than those who receive no
training (strong direct evidence: [47, 49, 52, 53, 55]).
It is noteworthy that in one study the number of
pharmacy users actually counselled per pharmacist trained
was very low (limited evidence [52]). A systematic review
covering smoking cessation training and other behavioural
interventions by pharmacists noted the near-absence of
evidence on what is actually delivered to pharmacy
customers following a training course (moderate direct and
strong indirect evidence [74]).
Question 2: What is the perspective of patients and the
public on pharmacy-based smoking cessation support and
other non-dispensing roles of the pharmacist?
Members of the public who are counselled by a trained
pharmacist about smoking cessation are likely to value the
intervention, to find it helpful and to consider it
appropriate that the pharmacist delivered it (limited
evidence [55]). The same is true of other behavioural
counselling – for example in support for asthma self-care (limited
evidence [64]). Despite this, some pharmacy-based quit
programmes are not widely used (strong direct evidence
[52, 57, 63, 65]). Surveys of pharmacy users suggest that
they may be unaware of the extended services provided by
pharmacists (moderate direct evidence [3, 57, 69]); some
lack confidence in the pharmacist’s non-dispending role
and may even view the pharmacist as someone with limited
skills, who works – or ought to work – under a GP’s
instructions (moderate direct evidence [3, 65, 69]). The
public’s top priority for pharmacy services is reliable supply
of prescription medicines (strong direct evidence [3, 57, 58,
64, 65, 69]); and they have concerns about the level of
privacy in pharmacy outlets – which may not be fully justified,
as many are unaware that pharmacists have rooms for
consulting in privacy (moderate direct evidence [3, 65, 69]).
Question 3: What do pharmacists perceive are the barriers
to delivering smoking cessation support?
Surveys of pharmacists have identified a number of perceived
barriers to delivering smoking cessation support as part of
business as usual in their high-street pharmacies. These
include personal characteristics of the pharmacist, namely a
perceived need for (further) training (strong direct evidence
[3, 13, 59, 61]); perceived lack of interest from patients
(strong direct evidence [59, 60]), perception that behavioural
counselling is beyond their role (strong direct evidence [3,
13, 61]), unwillingness to put a strain on their relationships
with ‘customers’ (moderate direct evidence [27, 65]), and a
dislike of counselling (limited evidence [61]). They also
include perceived features of the pharmacy and its local
environment: lack of time (strong direct evidence [3, 13, 59–61]),
lack of space – especially for consulting in private (strong
direct evidence [3, 13, 61]), difficulty in identifying which
customers are smokers at point of care (strong direct
evidence [59, 61]), lack of support staff (limited evidence [61]),
lack of specific remuneration (strong direct evidence [13, 27,
59]), other more pressing pharmacy duties, especially the
high workload of dispensing (strong direct evidence [3, 27,
61, 65]), lack of ongoing relationships with customers (strong
direct evidence [13, 61]), lack of opportunity to network with
other primary care professionals (moderate direct evidence
[3, 13]), lack of support from the manager or owner of the
pharmacy (limited evidence [61]), excessive patient demand
(limited evidence [65]), lack of support from a local health
promotion unit (limited evidence [13]), and lack of national
and/or local publicity on what extended services were
available at pharmacies (limited evidence [3]).
One study found that whilst most pharmacists have a
room for consulting in private, this was considered
illsuited for social interaction and in practice was typically
used as a place to escape from the stressful environment
of the busy pharmacy, rather than for patient interaction
(limited evidence [65]). The education of undergraduate
pharmacists was also identified as a contextual barrier:
respondents in one study viewed their undergraduate
education as narrowly biomedical and drug-focused, making it
difficult for them to develop a public health perspective
on their professional role (moderate direct evidence [13]).
Question 4: What do pharmacists believe would help them
to deliver smoking cessation support?
In surveys, pharmacists have identified a number of
‘facilitators’ that would help them deliver smoking cessation
counselling. These include characteristics of the
pharmacist: a personal identity that embraces the public health role
(moderate direct evidence [13]), patient-centred values
(moderate direct evidence [13, 66]) and a strong sense of
professional ethics (limited indirect evidence [66]); a
perception that smoking cessation is ‘medicines-related’ and
hence part of the professional jurisdiction of the pharmacist
(moderate direct evidence [13]), a positive attitude to
smoking cessation counselling (strong direct evidence [13, 18,
61]), a belief that the counselling will be effective (strong
direct evidence [18, 61]) and speaking the same ethnic
language as the target customer(s) (limited evidence [13]).
They also include characteristics of the pharmacy: low job
stress (moderate direct evidence [13]), the extent to which
the pharmacist can work with known, regular customers
(moderate direct evidence [13]), and the introduction of
new pharmacy roles, especially the accredited pharmacy
checking technician to help with the ever-increasing
workload of dispensing (limited evidence [3]). Pharmacists
have acknowledged the worsening ethical dilemmas in
their role as a result of escalating commercial pressures,
contractual changes and public demand (moderate
indirect evidence [3, 65, 66]).
Whilst one study identified a ‘community’ ethos and
culture, namely, small size, stable local population and
tradition of providing preventive services (moderate
direct evidence [13]), as supportive of a public health
role of the pharmacist, respondents in another study
considered that large pharmacy chains were better
placed to develop the standard operating procedures,
promotional material and training packages to support
the delivery of novel services (limited evidence [3]).
System factors perceived by pharmacists to facilitate their
provision of smoking cessation counselling include
endorsement of the extended role of the pharmacist by
national directives and/or a professional body (moderate
direct evidence [13]) and the nature and quality of the
local primary care network (limited evidence [3]), since
“collaboration is important for signposting or for referring
into existing systems, ensuring holistic care, avoiding
duplication, ensuring targeting of different populations,
and enabling individuals to select their preferred public
health service provider” ([3], p. 279).
Question 5: How do organisational and system factors
influence uptake and delivery of smoking cessation
counselling by pharmacists?
We found little empirical evidence on this question but
we did identify several reviews and commentaries
considering policy drivers and business models.
In the UK, for example, there have been four policy
drivers towards an extended role of the community
pharmacist (towards either specific services such as
smoking cessation support or, as envisaged by some, a
comprehensive population-wide public health role
including health promotion, disease prevention and
disease management [26]) in recent years: the 2005 NHS
Pharmacy Contract; the notion of a ‘responsible
pharmacist’ who is present on site and supervising dispensing;
the introduction of Pharmacists with Special Interest;
and the regulation of the pharmacy workforce including
separate licensure of pharmacy technicians (limited
evidence [2]). Similar but not identical shifts in the scope
of pharmacy practice are occurring in other western
countries (moderate direct evidence [67, 72]).
The 2005 contract in the UK represents a number of
significant shifts for community pharmacies as businesses: in
the source of pharmacists’ income (from margins on
dispensed medicines to fees for services delivered); in the
definition of the pharmacist’s role (from ‘dispenser of
medicines’ to ‘prescriber,’ ‘supporter of self-care’ and
‘educator’); in the nature and extent of clinical governance
requirements (a significant increase in the amount of
paperwork for accountability, quality assurance and
accreditation), requiring organisational knowledge and
standard operating procedures; in skill mix (especially in relation
to assistants and technicians, as well as increasing
diversification and specialisation); and in the requirement for
training. These changes occur in the context of a rapid shift in
recent years from single, owner-occupied pharmacy
practices to larger chains – which now dominate the UK sector
and which, as noted above, may be better able to
weather these extensive changes in the business context.
In turbulent times, the ability to adapt rapidly and
appropriately to external policy changes is key to the
survival of a pharmacy as a business. A qualitative interview
study from Australia sought to identify the capacity of
current pharmacy business models, and in particular the
dimensions of organisational flexibility within these
models, to integrate both the traditional product
(medicines) focus and the new extended role (services) of
pharmacists (limited evidence [67]). The authors
identified four kinds of organisational flexibility from the
business and management literature:
Steady-state (limited flexibility, centred on the
status quo, resistant to any change);
Operational flexibility (able to react to short-term
market demands but incapable of making significant
structural or strategic changes);
Structural flexibility (able to use managerial
capabilities to alter a firm’s structure to respond
to internal and external pressures, hence can
embrace medium-term change);
Strategic flexibility (able to engage proactively and
strategically to accommodate change and embrace
opportunities, hence can embrace long-term
change).
The authors found four types of community pharmacy
in their (Australian) setting: the traditional, small
dispensing pharmacy that offers few additional services and
representing the steady-state; larger retail pharmacies
with higher throughput of goods and typically exhibiting
operational flexibility to increase and vary the product
range in retail sales; the ‘healthcare solution pharmacy’
(based on creating a professional image as healthcare
providers and the provision of services, and perhaps
offering niche services from specialist employees); and
the networked pharmacy (two or three pharmacies
connected through a shared ownership structure) – different
pharmacies offer different products and services based
on reaching critical mass (or economies of scale) and
position themselves effectively to the local competition.
Both healthcare solution pharmacies and networked
pharmacies tend to exhibit either structural flexibility
(i.e. they develop services in a few key areas and change
structure to implement these) or strategic flexibility (i.e.
they pro-actively plan and integrate new services into
the brand image of the pharmacy and support these
through development of internal systems, staff and
practices). Strategic questions include skill mix, the structural
and material environment of the pharmacy, return on
investment, and marketing and communication activity.
Importantly, the emergence and adoption of new business
models in existing and new pharmacies in the local
environment stimulates a shift in the business model of
neighbouring pharmacies since competition promotes
service development (moderate direct evidence [67]).
Whilst business models in the UK and elsewhere for
delivering pharmacy products and services have changed
rapidly since the early 2000s, there is some evidence that
models of financial remuneration have lagged behind
these changes. A systematic review of remuneration
models for pharmaceutical professional services in
different countries found that, in most existing models,
pharmacists’ income remains linked primarily to the
medicines dispensed, though in many countries there is
now a significant income stream linked to managing the
use of these medicines and liaising with general practice
to maximise safety and minimise waste (strong direct
evidence [76]). Most countries regulate remuneration for
services only when the medicine is paid for under a
national reimbursement scheme. Two reasons for the
absence of attractive remuneration schemes for
pharmacy professional services (defined as “the contribution
of pharmacists and their assistants to medicines therapy
as a part of the total care supplied to patients, in
cooperation with physicians and other health care
professionals, with a view to optimizing the efficiency, the
effectiveness and the safety of medicines” [76]) in many
countries are a fixed overall budget (hence, increased
funding for professional services will reduce the amount
available for dispensing and medicines management)
and lack of evidence on the cost-effectiveness of these
services (strong direct evidence [76]).
The discussion and policy papers in our sample highlight
an inherent ambiguity in the pharmacist’s role, which
combines retail (hence, the business incentive to offer products
of limited therapeutic value to meet consumer demand,
and to foster a ‘customer is always right’ ethos) with
professional services (hence, the pressure to be ‘evidence-based’
and challenge consumer choices where appropriate) [3, 27].
This role ambiguity is perceived to be exacerbated by
imposed targets and a task-oriented approach to policy [76].
The issue of professional jurisdiction was a key theme in
the discussion papers in our sample. When one profession
seeks to take over an aspect of the core practice of another
profession, the latter may view this as competition. General
practitioners in the UK have expressed confidence in
pharmacists’ core role of dispensing and monitoring medicines
but voiced concerns about their competence to provide
pharmacy professional services (limited evidence [3]). In
some countries, notably the USA, competition has been
formally managed by the introduction of Collaborative Practice
Agreements between physicians and pharmacists, though
such agreements are not yet widespread (strong direct
evidence [25]). The introduction and extension of professional
recognition, credentialing and privileging may also aid the
development of an accepted professional jurisdiction in
pharmacy professional services, though progress on this matter is
slowed by poor agreement across countries in the definition
of pharmacy professional services and the nature and level of
training required to deliver it (strong direct evidence [25]).
Realist analysis: what might work for whom?
Based on the above descriptive synthesis, we identified five
mechanisms by which a programme to deliver smoking
cessation support via community pharmacists might achieve its
goals (typically measured in terms of clients counselled, quit
rates achieved and quit rates sustained) and built tentative
theories to explain the influence of context on these
mechanisms (see example in Box 1). The mechanisms were
pharmacist identity, pharmacist motivation, pharmacist
capability (knowledge, competence), clinician confidence and
public trust. Whilst all these mechanisms were identified
primarily from the empirical studies included in this review,
they also align with a wider literature – which we were not
resourced to review comprehensively – on the psychology
of behaviour change and the adoption of innovations
(discussed in relevant sections below), and on policy for
pharmacist education and development [77]. We consider
the five mechanisms in turn below.
Mechanism 1: Pharmacist identity
Most studies in our sample studied pharmacists rather than
other staff employed in pharmacies (this is probably due to
the relatively recent introduction of the role of pharmacy
assistant). Pharmacists are more likely to want to deliver
smoking cessation if they see themselves as having a public
health function (and not merely as a dispenser of
medicines); if they are patient-oriented rather than
productoriented and if they have a strong sense of professional
ethics. The primary studies in our sample identified three key
contextual influences on these elements of identity. First,
undergraduate education that is oriented towards nurturing
these characteristics will tend to produce new pharmacy
graduates who are likely to accept their extended role and
gain fulfilment from it. Second, this sense of identity is likely
to be sustained if professional bodies embrace the extended
role and engage proactively in the postgraduate
development of pharmacists in a way that explicitly goes beyond
dispensing. Thirdly, it is also likely to be sustained if
policymakers view pharmacists as professionals (and the delivery
of public health services as a professional role) rather than
viewing pharmacists as individuals who could be incentivised
to perform a technical task, and if they engage in dialogue
with professional bodies to address conflicts between
pharmacists’ professional role and their business role.
Mechanism 2: Pharmacist capability
Pharmacists (or staff employed by them) are more likely
to want to deliver smoking cessation services, and to
actually deliver them, if they are knowledgeable about the
topic, confident in their own ability to deliver behavioural
counselling (self-efficacy) and have good communication
skills, and if they believe their intervention will be
effective. Contextual influences that are likely to affect these
elements of pharmacist capability relate to the quality,
depth and breadth of the training at both undergraduate
and postgraduate level, whether such training is accessible
(and actually accessed) throughout the professional life of
the pharmacist and the extent to which it addresses skills
and attitudes as well as just knowledge.
Mechanism 3: Pharmacist motivation
The empirical evidence shows that motivated staff are
more likely to deliver smoking cessation counselling. This
motivation can be divided into professional motivation,
personal motivation and business motivation. Contextual
factors likely to enhance professional motivation include
the involvement of other pharmacists (and pharmacies) in
smoking cessation, setting a strong professional norm
against which other pharmacists would benchmark their
own practice, and receiving positive feedback at
professional appraisals. Personal motivation is likely to be higher
in contexts where the trade-off between remuneration
and the paperwork of claiming this remuneration is
favourable. Factors likely to enhance business motivation
include a business model that makes it worthwhile to
invest in space, staff training and necessary infrastructure.
It should be noted that most studies in our sample were
undertaken on pharmacists at a time when the
predominant business model (in the UK and elsewhere) was the small
‘owner-occupied’ dispensing pharmacy. Motivation of
pharmacists in this position may be different from that of a
salaried pharmacist in a large chain or a pharmacy assistant.
The above three mechanisms, all relating to pharmacist
behaviour, resonate with the wider theoretical literature on
learning and behaviour change. In the theory of planned
behaviour, Ajzen proposed that, if people evaluate a behaviour
as positive in terms of outcomes and importance of that
outcome (attitude) and if they think significant others whom
they value want them to perform the behaviour (subjective
norm), this results in a higher intention (motivation) and
they are more likely to do so, provided they perceive they
have control to do so and that any external constraints to
achieving the suggested behaviour are removed [78].
Bandura’s social learning theory proposes that people are
more likely to change their behaviour if the training
addresses expectancies about the likely benefits of the
intervention and includes (in addition to factual knowledge)
exposure to positive role models, attention to particular
skills, development of self-efficacy (confidence in one’s
ability to apply those skills), and environmental support to use
those skills [79]. Rogers’ diffusion of innovations theory
further expanded the complex and powerful phenomenon of
peer influence among health professionals [80].
Also relevant is Grol’s five-stage theory of change
among health professionals, comprising orientation (in
which the potential adopter becomes aware of, and
interested in, a new approach), insight (in which they come to
understand the innovation and also understand the
limitations of their current practice), acceptance (in which they
develop a positive attitude to change as well as the
intention to change), change (in which they start
exhibiting the new behaviour and confirm its value), and
maintenance (in which they work to embed the new practice
into personal and organisational routines) [81]. Whilst
none of the primary studies we reviewed explicitly set out
to test these theories of behaviour change, their findings
are very consistent with this wider theoretical literature.
Mechanism 4: Clinician confidence
As noted above, smoking cessation interventions delivered
in community pharmacies are critically dependent on a
strong referral pathway from general practitioners [3], but
empirical evidence suggests that this pathway, even in a
research setting, is often weak [52, 57, 63, 65]. In one
study, this was explained by the fact that referring general
practitioners had low confidence in pharmacists’ capability
to deliver smoking cessation support [3]. This may in turn
partially reflect pharmacists’ own lack of confidence and/
or willingness to take on a smoking cessation role
(described above). The primary studies in our sample suggest
that clinician confidence may be enhanced by positive
messages in professional journals about the pharmacist’s
extended role; a positive attitude and actions from doctors’
professional bodies; and a local primary care network that
understands, acknowledges and is willing to signpost and
affirm this role among community pharmacists.
Mechanism 5: Public trust
As noted in the descriptive findings, primary studies
suggested that public confidence and trust in
pharmacists to deliver smoking cessation support is limited.
Much of that primary data emphasised the public’s
lack of awareness and exposure to public health and
health promotion activity by pharmacists. A focus
group study in the UK explored reasons for lack of
trust in pharmacists relative to general practitioners
[69]. It identified numerous system-based factors that
reinforce patient trust and confidence in general
practitioners, including the registered list system,
appointment systems, the general practice expert and
gatekeeper role, the physical environment of the
practice, and good understanding of the training of
doctors. These factors all helped to foster familiarity with
a specific doctor or practice, which allowed
interpersonal trust to develop. In contrast, participants had
much more limited and less consistent exposure to
community pharmacists and more limited knowledge
of how they were trained and their systems for
practice. Other studies in our sample suggested additional
contextual factors that will tend to engender public
confidence and trust, include clear, consistent and
positive messages in the media about the pharmacist’s
extended role and positive messages on this topic
from general practitioners.
Figure 2 offers a provisional unifying model of the
above five mechanisms and the contextual influences on
them. For high-quality smoking cessation support to be
delivered to significant numbers of people in a
community pharmacy setting, three things need to happen.
First, pharmacists need to be willing and able to engage
in this activity – a function of their professional identity,
their specific capability to perform the role and their
motivation (which will be influenced both by
professional norms and by the practical and financial reality of
delivering on this aspect of their role in a busy pharmacy
setting). Second, there needs to be a clear and well-used
referral pathway, especially from local general practices;
this will depend on clinicians’ confidence in their
pharmacist colleagues and will be enhanced by positive
messages from their professional bodies and by
increased interprofessional interaction. Finally, the public
needs to have high confidence and trust in the extended
role of the pharmacist – something that may currently
be lacking but which could be increased by systematic
Fig. 2 Unifying model showing key influences on successful delivery of smoking cessation support in community pharmacies. White boxes represent
mechanisms; coloured boxed represent contextual influences that make each mechanism more likely to have effect; the grey box is the outcome
Discussion
Summary of findings and comparison with previous
findings
This qualitative review, which links to the findings of a
parallel quantitative review for the Cochrane EPOC group,
included a wide range of study designs written up in 66
papers. It summarises and extends a substantial existing
literature of systematic reviews (based on dozens of
primary studies) on community pharmacy-based smoking
cessation services. Most empirical studies on pharmacist
involvement in smoking cessation were small trials
undertaken by pharmacists; they focused on the impact of
training on the confidence and capability of
pharmacists and their staff (improved); pharmacists’ attitudes
to their extended role (mixed); pharmacists’ perceived
barriers to delivering smoking cessation (multiple,
including insufficient training, insufficient time or space,
insufficient interest from patients, inadequate
remuneration and more pressing priorities), and pharmacists’
views on what would help them deliver such a service
(multiple, including training, professional body support,
more time and space, and additional staff roles). There
was very limited empirical evidence on organisational
and system influences on this extended role.
Our findings substantiate some key recommendations
of previous systematic reviews: that pharmacists and
their staff, when properly trained and supported, are
capable of delivering the non-dispensing elements of a
smoking cessation service as well as providing nicotine
replacement products [4, 15–18, 20, 74, 75, 76]; that
training improves their confidence and performance in
this area [74, 75]; that there may be role ambiguity and/or
issues of professional identity when pharmacists are
invited to take on non-dispensing roles [13]; that primary
studies have, to date, produced a very limited evidence
base on the real-world implementation of smoking
cessation services (for example, the active components of
interventions have been poorly described and rarely theorised)
[4, 13, 17, 20, 74]; that pharmacies may be run according
to different business models but the evidence base on how
these different models support non-dispensing pharmacy
services is limited [4, 76]; and that there are policy
implications of a major change in the professional jurisdiction
of pharmacists [4, 17].
Our review adds to the existing literature by going
beyond the search for ‘active components’ of a generic
smoking cessation intervention and offering a more
nuanced and theoretically informed analysis in a provisional
realist analysis. Key findings from our realist analysis are
that, firstly, for the community pharmacy to become the
site of smoking cessation support, the pharmacist needs to
view themselves as a public health professional rather than
(merely) a dispenser of medicines – something that is far
more likely to happen if undergraduate training,
professional bodies and national policy depicts them in this way
and endorses the role positively. Secondly, that training
(oriented to increasing knowledge, communication, belief
in one’s ability to deliver the intervention and belief in the
efficacy of the intervention) is more likely to be effective
at both undergraduate and postgraduate level if courses
are affordable and accessible and if a broad curriculum is
provided that goes beyond ‘tasks and facts’. Thirdly, that
pharmacists are more likely to be motivated (from a
professional, business and personal perspective) to deliver
smoking cessation services if other pharmacists locally
and nationally are also doing so; if the work is received
positively at appraisal and performance review; if
structural and logistical issues (time, space, priorities) are
addressed; and if the work is adequately remunerated and
avoids excessive claims paperwork. Finally, the shift to
include smoking cessation services – as with other aspects
of the non-dispensing role of the pharmacist – must have
the confidence of other health professionals (especially
general practitioners) and the trust of the wider public;
this is more likely to happen if clear, consistent and
positive messages are provided from the wider community of
local health providers, doctors’ professional bodies and
the media.
Early qualitative work by our own group on the STOP
study confirms a number of barriers identified in this
realist review, including, for example, pharmacy workers’
reluctance to risk threatening the relationship with
‘customers’; difficulties experienced by (often junior)
pharmacy staff identifying who is a smoker at the
pharmacy counter; the crucial importance of support from
top and middle managers; and low public awareness of,
and confidence in, the community pharmacy as a place
to access smoking cessation support [82]. Our findings
also confirm that a strong sense of professional ethics
and a ‘public health’ orientation are associated with
keenness to provide smoking cessation services; and that
in multi-ethnic areas, pharmacy assistants (who may
deliver the smoking cessation intervention) are more
likely than pharmacists to reflect the diverse ethnic
backgrounds of customers [82].
Strengths, limitations and future research directions
This review followed the international RAMESES
guidelines for realist synthesis [9]. The strengths of realist
review have been described in detail in that paper. Briefly,
such reviews are highly nuanced and go beyond the
grand mean of ‘effect size’ to consider what
interventions will work well (and less well) for whom in that
circumstances – hence they can inform how
interventions might be optimised for local delivery and impact
maximised. This review included a wide range of study
designs undertaken by different disciplinary teams with
different goals, and has begun to tease out key
interactions between the theoretical mechanisms of success and
the context in which the intervention could or might be
delivered. As such, it makes an important potential
contribution to informing the development of policy both in
the UK and elsewhere.
The main limitation of this review is that the primary
data were largely atheoretical and highly skewed towards
the assessment of the attitudes, capabilities and response
to training of individual pharmacists. Most studies
included little or no contextual detail with which to build
theory about organisational and system influences (for
example, only two of 61 primary studies mention the word
‘contract’ [2, 35] and very few systematically addressed the
business aspects of pharmacist-led smoking cessation
services. As noted in the methods section, naturalistic studies
of how pharmacy work is conducted in practice were
absent from our sample. These limitations mean that the
context–mechanism–outcome links proposed in our
findings section are preliminary and should be subject
to further empirical testing.
Potentially, a wider range of literature (both theoretical
and empirical) could have been brought to bear on the
development of our theoretical model, since realist
reviews may include any studies that contribute to the
development of theory on a topic, whether or not they
themselves cover the same topic. Whilst we did include
studies of pharmacy practice beyond smoking cessation
support where these contributed to theory building, we
were not resourced to extend the review further.
This review was undertaken in parallel with the
iterative development and refinement of a complex
intervention for the STOP trial. Early interviews in preparation
for the STOP trial have confirmed the findings of
previous studies in relation to pharmacists’ (and
pharmacy workers’) perceived need for additional training
and support if they were to deliver an effective smoking
cessation service [82].
The findings from this review that identity, capability and
motivation of the pharmacist were key mechanisms
influencing the delivery of smoking cessation interventions, and that
these were mediated by the type, frequency and duration of
training as well as by numerous contextual influences,
contributed to the design of the pharmacist training intervention.
These constructs have been integrated within the intervention
being delivered in the ongoing STOP trial (which was guided
by both the ‘capability, opportunity, motivation and behavior’
model of behaviour, incorporating key domains of capability,
opportunity and motivation, as well as more detailed
behavioural theories such as social cognitive theory and
selfdetermination theory [83]). The intervention is described in
detail in a separate publication (in preparation).
Conclusion and recommendations
Smoking cessation support in community pharmacies
has been extensively studied but few firm conclusions
are yet possible on how best (if at all) to introduce this
as a national policy. There is now an extensive and
reasonably robust existing literature on individual behaviour
change (how to train and support pharmacists and their
staff, and the impact on patients), and also on individual
pharmacists’ attitudes and perceived barriers to change.
It is evident from our provisional model that
numerous factors will need to combine and interact over time
to generate a successful programme of high-quality,
pharmacist-led smoking cessation support. These
include (but may not be limited to) policy support,
undergraduate and postgraduate training of pharmacists,
professional sharing of practice and growing stakeholder
confidence. A number of ongoing natural experiments
have the potential to generate case study data on how
these influences play out in different national and
professional settings – and hence inform refinement of the
provisional model proposed here.
A reviewer of an earlier draft of this paper pointed out
the similarities between smoking cessation support and
alcohol advice in a pharmacy setting. In both cases, the
pharmacist is required to take on additional tasks and
also a person-focused and public health perspective.
One way of doing this in a time-efficient manner might
be to include questions about smoking and alcohol in
pharmacist-led medication reviews. Such an approach
has not (to our knowledge) been tested specifically,
though there is wider evidence that a ‘care bundle’
(that is, a small set of evidence-based interventions for
a defined patient population and care setting) can greatly
improve both processes and outcomes of care [84].
Our findings suggest that a high priority for further
research is the organisational and system context for
community pharmacy-based smoking cessation (especially
how different business models for delivering pharmacy
services may shape, enable and constrain pharmacists’
extended role) and on the costs and cost-effectiveness of
a pharmacist-led model compared to other modes of
delivery. Finally, a striking finding in the sample of
primary studies identified for this review was the
nearabsence of theoretically informed studies; further
empirical studies of pharmacist-led smoking cessation
should see both to apply and test relevant theories of
individual and organisational change. The ongoing
STOP trial is addressing organisational influences via a
detailed process evaluation and also includes a
costeffectiveness analysis [5].
Availability of data and material
EndNote database of studies with authors’ quality scores available on request.
Authors’ contributions
This study is a sub-study of the STOP programme on which RW is chief
investigator and LS and TG are co-investigators. LS is the lead on the parallel
quantitative review from which the original sample of 103 primary studies
was obtained. FM undertook initial searching, title screening and data extraction
for this study, supported by TG. TG developed the context-mechanism-outcome
configurations, supported by FM. TG drafted and revised the paper with input
from other authors. RW and LS provided feedback on drafts of the manuscript
and links to the wider STOP study. All authors have seen and approved the
final manuscript.
Competing interests
All authors have completed the ICMJE uniform disclosure form at http://
www.icmje.org/about-icmje/faqs/conflict-of-interest-disclosure-forms/ and
declare: no support from any organisation for the submitted work save for
funders listed above, no financial relationships with any organisations that
might have an interest in the submitted work in the previous 3 years, and
no other relationships or activities that could appear to have influenced the
submitted work.
Consent for publication
Not needed (secondary research).
Ethics approval and consent to participate
Not needed (secondary research).
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